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Medical device recalls: November 2013

The FDA posted 303 medical device recall records in November 2013, from 145 recall events by 95 companies. 12 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Synthes USA HQ, Inc. · 19 events, 20 records
  2. Siemens Medical Solutions USA, Inc · 5 events, 5 records
  3. Hospira Inc. · 4 events, 18 records, 2 Class I
  4. Beckman Coulter Inc. · 4 events, 5 records
  5. Baxter Healthcare Corp. · 4 events, 4 records
  6. Carestream Health Inc. · 3 events, 53 records
  7. GE Healthcare, LLC · 3 events, 3 records
  8. Zimmer, Inc. · 3 events, 3 records

FDA root cause

  1. Software design · 71
  2. Equipment maintenance · 41
  3. Device Design · 36
  4. Nonconforming Material/Component · 29
  5. Process control · 19
  6. Material/Component Contamination · 13
  7. Component design/selection · 13
  8. Employee error · 10

Class I recalls (12)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (283)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (8)

Using the device is not likely to cause health problems, but it violates FDA rules.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.